Concomitant Sparsentan (SPAR) and Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2i) in Patients with IgA Nephropathy (IgAN) in the PROTECT Open-Label Extension (OLE)
Topics: Nephrology IgAN Sparsentan Phase 3 PROTECT OLE
About the research
Summary
Background
- Sparsentan is a non-immunosuppressive, Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved for use in adults with IgA nephropathy who are at risk for disease progression1-5
- It has demonstrated sustained proteinuria reduction and preservation of kidney function in the PROTECT study6
- In clinical studies, sodium-glucose cotransporter-2 inhibitors (SGLT2i) reduced the risk of progression to kidney failure in patients with IgA nephropathy7,8
- Previous clinical data from the PROTECT open-label extension (OLE) indicated that adding an SGLT2i to stable sparsentan was generally well tolerated and demonstrated a benefit on proteinuria reduction9
Aim
This analysis of the ongoing PROTECT OLE period evaluated the safety and efficacy of stable sparsentan with the addition of an SGLT2i in IgA nephropathy1
Approach
- All patients who completed the double-blind period and met the eligibility criteria were enrolled in the OLE period1
- This analysis will assess data from a subset of patients who chose to receive concomitant treatment during the PROTECT OLE period1
Key findings
- Adding an SGLT2i to stable sparsentan1:
- Demonstrated further reduction in proteinuria (urine protein-creatinine ratio [UPCR])
- Showed relatively stable body weight and blood pressure over time
- Adding an SGLT2i to stable sparsentan was generally well tolerated – no cases of Hy’s Law were reported1
Read more about concomitant use of sparsentan and an SGLT2i in the SPARTACUS study and in a case series describing real-world experience.
Conclusions
- Based on recommendations from the draft updated KDIGO guidelines, sparsentan in combination with SGLT2i may represent an effective and safe treatment for patients with IgA nephropathy1,10
- Findings from this analysis are consistent with the additive benefit on proteinuria reduction seen by adding SGLT2i to stable sparsentan, and combination treatment was generally well tolerated1
Related content
Footnotes
DEARA, Dual Endothelin Angiotensin Receptor Antagonist; IgA, immunoglobulin A; OLE, open-label extension; SGLT2i, sodium-glucose cotransporter-2 inhibitor; UPCR, urine protein-creatinine ratio.
- Kooienga I et al. Poster presented at: American Society of Nephrology Kidney Week 2024; October 23-27, 2024; San Diego, CA. FR-PO851.
- Kohan DE et al. Clin Sci. 2024;138(11):645-662.
- FILSPARI® (sparsentan) Prescribing Information. San Diego, CA: Travere Therapeutics, Inc. 9/2024.
- FILSPARI® (sparsentan) Summary of Product Characteristics. Paris, France: Vifor France. 7/2024.
- Trachtman H et al. Expert Rev Clin Immunol. 2024;20(6):571-576.
- Rovin BH et al. Lancet. 2023;402(10417):2077-2090.
- Wheeler DC et al. Kidney Int. 2021;100(1):215-224.
- EMPA-KIDNEY Collaborative Group. N Engl J Med. 2023;388(2):117-127.
- Kooienga I et al. Poster presented at: American Society of Nephrology Kidney Week 2023; November 2-5, 2023; Philadelphia, PA. SA-PO903.
- KDIGO Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV). Accessed 22 October 2024. https://kdigo.org/wp-content/uploads/2024/08/KDIGO-2024-IgAN-IgAV-Guideline-Public-Review-Draft.pdf
MA-SP-24-0132 | November 2024